MAUDE Adverse Event Report: MAQUET, INC CARDIOHELP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number CARDIOHELP

Device Problems Occlusion Within Device (1423); Increase in Pressure (1491); Device Dislodged or Dislocated (2923); No Flow (2991)

Patient Problems Death (1802); Exsanguination (1841); Neurological Deficit/Dysfunction (1982)

Event Date 07/12/2015

Event Type  Death  

Event Description

Patient had successful completion of surgical repair of complete atrioventricular canal defect.Two days post-op, patient aspirated, and ecmo was required for recovery.After 72 hours, clinicians noted a gradually increasing outflow pressure within the patient's ecmo circuit.There was no transmembrane gradient noted.No clots could be seen by visual/flashlight inspection.In the 76th hour of support there was sudden cessation of flow.Flow could not be resumed, a clot was suspected and the circuit changed out.During replacement of the circuit, the cannula became dislodged and the patient exsanguinated during cardiac compressions.The patient was recannulated and ecmo therapy was resumed using the new circuit.The patient expired on (b)(6) 2015 as care was withdrawn due to her neurological status.Manufacturer response for heart-lung system, cardiohelp (per site reporter): manufacturer inspected the device sometime after it was returned to them on 17 july 2015.(device was a loaner unit provided by mfr while our own unit was sent for repair.) mfr confirmed from a review of the device logs that it was the one involved in our incident.Manufacturer response for patient circuit, cardiohelp (per site reporter): patient circuit was discarded before manufacturer's agent could examine it.

• Brand Name: CARDIOHELP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET, INC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 5284913
• MDR Text Key: 33120470
• Report Number: 5284913
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Unknown
• Device Model Number: CARDIOHELP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/13/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/13/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/10/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 1 YR
• Patient Weight: 6